以硼替佐米为基础的多发性骨髓瘤维持治疗真实世界研究  

A Real-World Study of Bortezomib-Based Maintenance Therapy in Multiple Myeloma

作　　者：代明辉[1,3] 帅晓 吴俣[2] 况小红[1] 李秋玲[1] 王奎 DAI Minghui;SHUAI Xiao;WU Yu;KUANG Xiaohong;LI Qiuling;WANG Kui(Department of Hematology,The Third Hospital of Mianyang,Sichuan Mental Health Center,Mianyang 621000,China;Department of Hematology,West China Hospital,Sichuan University,Chengdu 610041,China;Department of Internal Medicine,Hongyuan County People's Hospital of Sichuan Province,Hongyuan 624400,China)

机构地区：[1]绵阳市第三人民医院(四川省精神卫生中心)血液内科,绵阳621000 [2]四川大学华西医院血液内科,成都610041 [3]四川省红原县人民医院内科,红原624400

出　　处：《西南医科大学学报》2025年第2期198-205,共8页Journal of Southwest Medical University

基　　金：四川省科技厅重点研发项目(2022YFS0191)。

摘　　要：目的分析不同硼替佐米给药模式对多发性骨髓瘤(multiple myeloma,MM)维持治疗的疗效、副作用及生存结局的影响。方法对2010年1月至2020年12月,四川大学华西医院血液内科和绵阳市第三人民医院血液内科收治的190例未进行自体造血干细胞移植的MM患者的临床资料进行回顾性分析。根据患者维持治疗方案分为A组(每3个月进行4次给药,共66例)和B组(每3个月进行6次给药,共124例)。所有患者均接受硼替佐米维持治疗共2年,疗效评估分为部分缓解(partial remission,PR)、非常好的部分缓解(very good partial remis-sion,VGPR)、完全缓解(complete remission,CR)、严格意义的完全缓解(strictly complete remission,s CR)及疾病进展(progressive disease,PD),随访时间为3年。生存分析采用Kaplan-Meier法,预后因素分析采用Cox比例风险模型。结果随访2年后,A组与B组疗效评估为PD的分别有22例(33.3%)和43例(34.7%),差异无统计学意义(P=0.098)。A组和B组3年无进展生存(progression free survival,PFS)率分别为57.6%和67.6%,3年总生存(overall survival,OS)率分别为70.2%和78.0%,差异均无统计学意义(P=0.125,P=0.232)。标危患者PFS和OS优于高危患者,差异具有统计学意义(P<0.05)。多因素分析显示,性别(男性)、高ECOG评分、高球蛋白水平和治疗期间停药为疾病进展的独立危险因素(P<0.05)。副反应发生率A组和B组分别为25.8%和16.1%,差异无统计学意义(P=0.111)。危险分层及维持治疗后的疗效是影响PFS的独立因素(P<0.05);年龄、危险分层、ECOG评分是影响OS的独立危险因素(P<0.05)。其中,危险分层是影响PFS和OS的共同独立危险因素。结论硼替佐米维持治疗在不同危险分层和年龄组MM患者中均表现出较好的疗效和安全性,且A组治疗方案在临床应用中更具优势。Objective To analyze the effects of different bortezomib dosing patterns on the efficacy,side effects,and sur⁃vival outcomes of maintenance therapy for multiple myeloma(MM).Methods This retrospective study analyzed 190 multiple myeloma(MM)patients who did not undergo autologous hematopoietic stem cell transplantation(ASCT)and were treated at the Department of Hematology,West China Hospital of Sichuan University,and the Department of Hematology,the Third Hospital of Mianyang,between January 2010 and December 2020.Patients were divided into two groups based on the maintenance therapy regi⁃men:Group A(n=66),receiving four doses of bortezomib every three months,and Group B(n=124),receiving six doses every three months.All patients received bortezomib-based maintenance therapy for a total of two years.Treatment efficacy was assessed based on the following criteria:partial remission(PR),very good partial remission(VGPR),complete remission(CR),stringent complete remission(sCR),and progressive disease(PD).The follow-up period was three years.Survival analysis was performed using the Kaplan-Meier method,and prognostic factors were analyzed using the Cox proportional hazards model.Results After two years of follow-up,the number of patients with progressive disease(PD)was 22(33.3%)in Group A and 43(34.7%)in Group B,with no sig⁃nificant difference in efficacy between the two groups(P=0.098).The 3-year progression-free survival(PFS)rates for Group A and Group B were 57.6%and 67.6%,respectively(P=0.125),and the 3-year overall survival(OS)rates were 70.2%and 78.0%,respec⁃tively(P=0.232).The PFS and OS were significantly better in the low-risk group compared to the high-risk group(P<0.05).Multivariate analysis revealed that male gender,high Eastern Cooperative Oncology Group(ECOG)performance status,elevated globulin levels,and treatment interruptions were independent risk factors for disease progression(P<0.05).The incidence of adverse events was 25.8%in Group A and 16.1%in Group B,with no significant difference between

关 键 词：多发性骨髓瘤 硼替佐米 维持治疗 

分 类 号：R559[医药卫生—血液循环系统疾病]